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FDA 510(k)

DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE

K-Number: K880411 · 1988-02-29

ApplicantDey Laboratories, Inc.
Decision Date1988-02-29
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Dey Laboratories, Inc.. It received FDA 510(k) clearance on 1988-02-29 under 510(k) number K880411. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE?

DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Dey Laboratories, Inc.. The 510(k) number is K880411.

When did DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE receive FDA 510(k) clearance?

DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE received FDA 510(k) clearance on 1988-02-29, under 510(k) number K880411.

Who is the listed applicant for DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE?

The FDA 510(k) record lists Dey Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE?

The FDA product code for DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE is CAF.

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Other records listing Dey Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972778DEY VIAL SODIUM CHLORIDE 3%K910239NEBU-SOL METERED DOSE DISPENSER (TM)K875011DEY-PAK PURIFIED WATER, USP, STERILEK875024DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USPK831532OCULAR IRRIGATING CANNULA

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Official Source

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